WHO Technical Report Series, No. 902, 2002
Basic elements of good manufacturing practices in
Poor-quality medicines are not only a health hazard, but a waste ofmoney for both governments and individual consumers, since theymay contain toxic substances that have been unintentionally added.
For example, in Haiti in 1996, more than 80 children died after receiv-ing a syrup for cough and colds containing glycerol contaminated withdiethylene glycol (1
). If the manufacturer had followed good manufac-turing practices (GMP), these deaths could have been prevented.
In addition, a medicine that contains little or none of the claimedactive ingredient will not have the intended therapeutic effect. Anantibiotic with some — but not enough — of the active ingredient willnot cure infections. Even worse, bacteria exposed to low levels of theantibiotic may not be killed and may become resistant to the drug,even at the correct dosage, putting more lives at risk.
Good manufacturing practices help boost pharmaceutical export
Most countries will accept the import and sale of medicines only ifthey have been manufactured according to internationally recognizedGMP. For this reason, governments seeking to promote their coun-try’s export of pharmaceuticals can do so by making GMP mandatoryfor all pharmaceutical production and by training their inspectors inGMP requirements.
What are good manufacturing practices?
GMP are that part of quality assurance which ensures that productsare consistently produced and controlled according to quality stan-dards. They are designed to minimize the main risks involved inpharmaceutical production that cannot be eliminated through testingof the final product. These risks are:
— the unexpected contamination of products, causing damage to
— incorrect labels on containers, which could mean that patients
— insufficient or too much active ingredient, resulting in ineffective
GMP cover all aspects of production, from the starting materials,premises and equipment to the training and personal hygiene of staff.
Detailed, written procedures are essential for each process that couldaffect the quality of the finished product. Systems must be establishedto provide documented proof that correct procedures are consistentlyfollowed at each step in the manufacturing process — every time aproduct is made.
WHO has established detailed guidelines for GMP (2
), and manycountries have formulated their own GMP requirements based onthose of WHO. Others have harmonized their requirements, e.g. inthe Association of South-East Asian Nations (ASEAN), in the Euro-pean Union and through the Pharmaceutical Inspection Convention.
Are good manufacturing practices necessary if there is a quality
Good quality must be built in during the manufacturing process;testing products after they have been manufactured is not enough.
GMP prevent errors that cannot be eliminated through quality con-trol of the finished product. Without GMP it is impossible to be surethat every unit of medicine is of the same quality as those tested in thelaboratory.
In the early 1970s, a manufacturer in the United Kingdom produced aninfusion fluid which caused the death of five patients because it washeavily contaminated with bacteria (3). Before distributing the fluid, themanufacturer had tested several bottles and found them to be sterile.
Eventually a technical fault was found in the sterilizer: the bottles at thebottom had not been properly sterilized. The bottles that the manufac-turer had tested were from the upper part, giving the false impression thatall the bottles were sterile.
Can manufacturers afford to implement good manufacturing
Making poor-quality products does not save money. In the long run,it is more expensive finding mistakes after they have been made thanpreventing them in the first place. GMP are designed to ensure thatmistakes do not occur.
Implementation of GMP is an investment in good-quality medicines,and will improve the health of both the individual patient and thecommunity, as well as benefiting the pharmaceutical industry andhealth professionals.
Making and distributing poor-quality medicines leads to loss ofcredibility for everyone, including public and private health care ser-vices and pharmaceutical manufacturers.
1. Fatalities associated with ingestion of diethylene glycol — contaminated
glycerol used to manufacture acetaminophen syrup — Haiti, November1995–June 1996. Morbidity and Mortality Weekly Report, 1996, 45(30):649–650.
2. Quality assurance of pharmaceuticals. A compendium of guidelines and
related materials. Vol. 2. Good manufacturing practices and inspection.
Geneva, World Health Organization, 1999.
3. Meers PD et al. Intravenous infusion of contaminated dextrose solution: the
Devonport incident. Lancet, 1973, ii(7839):1189–1192.
T h e n e w e ng l a n d j o u r na l o f m e dic i n e Anticholinergics for Patients with Asthma? Current guidelines for treating patients with asth- ondary comparison, which was for noninferior-ma whose symptoms are not controlled by a low ity, was between adding tiotropium and adding dose of an inhaled glucocorticoid alone recom- salmeterol. mend either doubling the glucocorticoid do
Finance MR2 Requirements Document Distributed to Project FRESH ESC on 8/30/00. This page is intentionally left blank . Finance MR2 Team: Irving Canner, Dave Cosgrove, Ray Foss, Nicole Genco, Pat Madsen, Joe Poulin, Kerry Scala, Jackie Snow I:\System_Replacement\Processes\MR2\ Finance\ Requirements Doc\000831 deliverable.doc Table of Contents . 1 . 1 . 2